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Emerging Adults Who Use Alcohol and Marijuana (HEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01473719
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

Tracking Information
First Submitted Date  ICMJE November 15, 2011
First Posted Date  ICMJE November 17, 2011
Last Update Posted Date September 18, 2017
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2011)
  • alcohol use [ Time Frame: 15 months ]
  • marijuana use [ Time Frame: 15 months ]
  • sexually transmitted infection [ Time Frame: 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01473719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emerging Adults Who Use Alcohol and Marijuana
Official Title  ICMJE Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana
Brief Summary The purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Use
  • Marijuana Use
  • Sexually Transmitted Infections
Intervention  ICMJE
  • Behavioral: motivational intervention
    7-session individual motivationally-based intervention
  • Behavioral: health education
    7 individual sessions focusing on health education
Study Arms  ICMJE
  • Active Comparator: motivational intervention
    7-session individual motivationally-based intervention
    Intervention: Behavioral: motivational intervention
  • Placebo Comparator: health education
    7-session individual session focusing on health education
    Intervention: Behavioral: health education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
566
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2011)
500
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be between the ages of 18 and 25
  • Binge drink (5 or more drinks in a 2-hour period for men, 4 or more for women) at least monthly
  • Use marijuana at least weekly
  • Have been heterosexually active in the past six months
  • Are not married
  • Have not been living with a sexual or romantic partner for more than 6 months
  • Be English speaking
  • Reside within 20 miles of Providence, RI and plans to stay in the geographic area for the next 15 months
  • Provide contact information for at least two verifiable locator persons

Exclusion Criteria:

  • Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana)
  • Have DSM-IV diagnosis of alcohol dependence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473719
Other Study ID Numbers  ICMJE R01AA020509( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Stein, MD, Butler Hospital
Study Sponsor  ICMJE Butler Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael D Stein, MD Butler Hospital
PRS Account Butler Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP